Description:
This is a Phase 3, randomized, double-blind, placebo-controlled, multinational, and
multicenter study to evaluate the efficacy of rovalpituzumab tesirine as maintenance therapy
following first-line platinum-based chemotherapy.
Title
- Brief Title: A Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Participants With Extensive Stage Small Cell Lung Cancer (MERU)
- Official Title: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects With Extensive Stage Small Cell Lung Cancer (MERU)
Clinical Trial IDs
- ORG STUDY ID:
M16-298
- SECONDARY ID:
2016-003503-64
- NCT ID:
NCT03033511
Conditions
- Small Cell Lung Cancer (SCLC)
Interventions
Drug | Synonyms | Arms |
---|
Rovalpituzumab tesirine | | Rovalpituzumab tesirine/dexamthasone |
Dexamethasone | | Rovalpituzumab tesirine/dexamthasone |
Placebo for rovalpituzumab tesirine | | Placebo |
Placebo for dexamethasone | | Placebo |
Purpose
This is a Phase 3, randomized, double-blind, placebo-controlled, multinational, and
multicenter study to evaluate the efficacy of rovalpituzumab tesirine as maintenance therapy
following first-line platinum-based chemotherapy.
Trial Arms
Name | Type | Description | Interventions |
---|
Rovalpituzumab tesirine/dexamthasone | Experimental | Rovalpituzumab tesirine/dexamethasone every 6 weeks (q6 wk); omit every 3 cycles | - Rovalpituzumab tesirine
- Dexamethasone
|
Placebo | Experimental | Placebo q6 wk; omit every 3 cycles | - Placebo for rovalpituzumab tesirine
- Placebo for dexamethasone
|
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed extensive-stage disease small cell lung
cancer (ED SCLC) with ongoing clinical benefit (stable disease [SD], partial response
[PR], or complete response [CR]) following completion of 4 cycles of first-line
platinum-based therapy
- At least 3 but no more than 9 weeks between the administration of the last cycle of
platinum-based chemotherapy and randomization.
- Participants with a history of central nervous system (CNS) metastases prior to the
initiation of first-line platinum-based chemotherapy must have received definitive
local treatment and have documentation of stable or improved CNS disease status
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
- Participants must have adequate bone marrow, renal and hepatic function
- Availability of archived or representative tumor material for assessment of DLL3
expression
Exclusion Criteria:
- Any prior systemic chemotherapy, small molecule inhibitors, immune checkpoint
inhibitors, other monoclonal antibodies, antibody-drug conjugates,
radioimmunoconjugates, T-cell or other cell-based or biologic therapies, or any other
anti-cancer therapy than that described in inclusion criteria
- Any disease-directed radiotherapy (except prophylactic cranial irradiation or
pre-planned radiotherapy for CNS metastases present prior to start of first-line
therapy and non-progressing) after last dose of first-line chemotherapy.
- Prior exposure to a pyrrolobenzodiazepine (PBD)- or indolinobenzodiazepine-based
drug, prior participation in a rovalpituzumab tesirine clinical trial, or known
hypersensitivity or other contraindications to rovalpituzumab tesirine or excipient
contained in the drug formulation.
Maximum Eligible Age: | 99 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Progression-free survival (PFS) determined by a Central Radiographic Assessment Committee (CRAC) |
Time Frame: | Approximately 24 months since the first subject enrolled |
Safety Issue: | |
Description: | PFS is defined as the number of months from randomization to disease progression, as assessed by the CRAC per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death of any cause, whichever occurs first. |
Secondary Outcome Measures
Measure: | Objective response rate (ORR) per the CRAC based on RECIST v1.1 |
Time Frame: | Approximately 31 months since first subject enrolled |
Safety Issue: | |
Description: | ORR the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) per CRAC according to RECIST version 1.1 from the date of randomization until disease progression or death, whichever occurs first. |
Measure: | Change in patient reported outcomes (PROs)--physical functioning domain |
Time Frame: | Approximately 31 months since first subject enrolled |
Safety Issue: | |
Description: | EORTC QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including global health status/quality of life, functional scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Lung Cancer Module (QLQ-LC13) is a supplementary lung cancer-specific questionnaire to be used in conjunction with the EORTC QLQ-C30 |
Measure: | Progression-free survival (PFS) per investigator assessment based on RECIST v1.1 |
Time Frame: | Approximately 24 months since the first subject enrolled |
Safety Issue: | |
Description: | PFS is defined as the number of months from randomization to disease progression, as assessed by the investigator per RECIST version 1.1, or death of any cause, whichever occurs first. |
Measure: | ORR per investigator assessment based on RECIST v1.1 |
Time Frame: | Approximately 31 months since first subject enrolled |
Safety Issue: | |
Description: | ORR is the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) per investigator assessment according to RECIST version 1.1 from the date of randomization until disease progression or death, whichever occurs first. |
Measure: | Clinical benefit rate (CBR) per the CRAC assessment based on RECIST v1.1 |
Time Frame: | Approximately 31 months since first subject enrolled |
Safety Issue: | |
Description: | CBR is the percentage of participants whose best overall response is either CR, PR, or stable disease (SD) per CRAC according to RECIST version 1.1 from the date of randomization until disease progression or death, whichever occurs first. |
Measure: | CBR per the investigator assessment based on RECIST v1.1 |
Time Frame: | Approximately 31 months since first subject enrolled |
Safety Issue: | |
Description: | CBR is the percentage of participants whose best overall response is either CR, PR, or stable disease (SD) per investigator from the date of randomization until disease progression or death, whichever occurs first. |
Measure: | Duration of response (DOR) per the CRAC assessment |
Time Frame: | Approximately 31 months since first subject enrolled |
Safety Issue: | |
Description: | DOR is the time from the initial objective response (CR/PR) by CRAC to disease progression or death, whichever occurs first. |
Measure: | DOR per the investigator assessment |
Time Frame: | Approximately 31 months since first subject enrolled |
Safety Issue: | |
Description: | DOR is the time from the initial objective response (CR/PR) by investigator to disease progression by investigator or death, whichever occurs first. |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | AbbVie |
Trial Keywords
- Extensive-Stage Small Cell Lung Cancer (ED SCLC)
- Rovalpituzumab tesirine
- first-line chemotherapy
- Cancer
- Platinum-Based Chemotherapy
Last Updated
March 30, 2017